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United States · US · US:82791-362_1d9a1236-b360-4be1-e063-6294a90a27d6

Julie Cold Sore Treatment

Orange BookUNIISPLATC D06BB11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerJulie Products Inc
CountryUS (United States)
ATC codeD06BB11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8279136201
    2 g in 1 TUBE (82791-362-01)

Annotations

UNII (FDA Substance ID)
9G1OE216XY
DOCOSANOL
RxCUI 594680
Orange Book
A217090
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9G1OE216XY",
    "rxcui": "594680",
    "inchikey": "NOPFSRXAKWQILS-UHFFFAOYSA-N",
    "display_name": "DOCOSANOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "40bb96f0-d5f1-1ec3-e063-6294a90a74b1": {
      "match": "brand_token",
      "title": "JULIE MORNING AFTER PILL (LEVONORGESTREL) TABLET [JULIE PRODUCTS INC.]",
      "spl_version": "2",
      "published_date": "2025-11-27"
    }
  },
  "productid": "82791-362_1d9a1236-b360-4be1-e063-6294a90a27d6",
  "productndc": "82791-362",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "217090",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Mar 1, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DOCOSANOL",
  "proprietary_name": "Julie Cold Sore Treatment",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA217090",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docosanol",
  "start_marketing_date": "20240702",
  "active_numerator_strength": "100"
}

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